CATHRX STARTS AUSTRALIAN REGULATORY TRIAL
November 22nd 2008 01:19
Wednesday November 19, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: SUNSHINE UP 25%, PHOSPHAGENICS DOWN 12%
* DR MERVYN JACOBSON REDIRECTS GENETIC TECHNOLOGIES
* CATHRX STARTS AUSTRALIAN REGULATORY TRIAL
* PRECLINICAL DATA BACKS NEURODISCOVERY PAIN DRUG
* US PATENT FOR ANTISENSE’S ATL1101 FOR CANCERS
* JAPAN APPROVES ACRUX ‘CORE PATENT’
* GOODBYE PROTEOME, HELLO TYRIAN
* INNOVATION MINISTER OPENS ARANA’S NEW MELBOURNE FACILITY
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
CATHRX
Cathrx has begun a 60-patient clinical trial at Sydney’s Westmead Hospital for Australian Therapeutic Goods Administration approval of its diagnostic catheters.
Cathrx said Westmead Hospital was one of Australia’s largest teaching hospitals and a preeminent cardiology centre. The principal investigator is Dr Stuart Thomas.
Cathrx chief executive officer Neil Anderson said the Australian clinical trial would provide specific Australian clinical performance data in addition to that which it is gaining from sales in Europe.
“The catheters already have Conformitée Européenne (CE) marking approval for use in Europe but this trial will also allow the feedback from local clinical specialists,” Mr Anderson said.
The primary end-point for the Australian approval trial is a confirmation of diagnosis capability.
The protocol calls for the use of Cathrx’s catheter in 30 patients, compared with 30 control patients, undergoing electrophysiology or ablation procedures that require the use of diagnostic catheters. The data gathered will complement the submissions of a quality system audit and design dossier.
Cathrx said the process was similar to the CE marking approval process for Europe.
Cardiac catheters are minimally invasive tools widely used by specialist clinicians to diagnose and treat different types of cardiac arrhythmias.
The trial will investigate four-electrode and 10-electrode diagnostic catheters with a range of formable and deflectable stylets: small, medium, large and extra large.
Cathrx said enrolment was expected to be completed by July 2009 with a regulatory submission at the same time.
Cathrx was untraded at 65 cents.
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
| 22 |
| Vote |
Add To: 
subscribe to this blog